1. Field of the Invention
This invention relates to an at least partially implantable hearing system for rehabilitation of a hearing disorder comprising at least one acoustic sensor for picking up an acoustic signal and converting the acoustic signal into corresponding electrical audio sensor signals, an electronic signal processing unit for audio signal processing and amplification, an electrical power supply unit which supplies individual components of the system with energy, and at least one electromechanical output transducer driven by an electronic driver arrangement of the signal processing unit, wherein the electromechanical output transducer is provided with an active electromechanical element and an output member for stimulating, via a passive coupling element, an ossicle of a middle ear ossicular chain, which chain has a natural capability for vibratory movement.
2. Description of Related Art
Hearing systems are defined here as systems in which the acoustic signal is picked up with at least one sensor which converts the acoustic signal into an electrical signal (microphone function), which is electronically further processed and amplified, and whose output-side signal stimulates the damaged hearing electromechanically.
The expression xe2x80x9chearing disorderxe2x80x9d is defined here as inner ear damage, combined inner ear and middle ear damage, and a temporary or permanent noise impression (tinnitus).
Electronic measures for rehabilitation of inner ear damage which cannot be cured by surgery have currently achieved great importance. With total failure of the inner ear, cochlear implants with direct electrical stimulation of the remaining auditory nerves are in routine clinical use. For medium to severe inner ear damage, for the first time, fully digital hearing devices are presently being used which open up a new world of electronic audio signal processing and offer expanded possibilities of controlled audiological fine tuning of the hearing devices to the individual inner ear damage. In spite of major improvements of hearing aid hardware achieved in recent years, in conventional hearing aids, there remain basic defects which are caused by the principle of acoustic amplification, i.e. especially by the reconversion of the electronically amplified signals in airborne sound. These defects include aspects such as the visibility of the hearing aids, poor sound quality as a result of electromagnetic transducers (speakers), closed external auditory canal as well as feedback effects with high acoustic gain.
As a result of these fundamental defects, there has long been the desire to move away from conventional hearing aids with acoustic stimulation of the damaged inner ear and to replace them by partially or fully implantable hearing systems with direct mechanical stimulation. Implantable hearing systems differ from conventional hearing aids: the acoustic signal is converted with a proper microphone into an electrical signal and amplified in an electronic signal processing stage; this amplified electrical signal, however, is not sent to an electroacoustic transducer (speaker), but to an implanted electromechanical transducer providing for output-side mechanical vibrations which are sent directly, therefore with direct mechanical contact, to the middle ear or inner ear, or indirectly via an air gap in, for example, electromagnetic converter systems. This principle applies regardless of whether implantation of all necessary system elements is partial or complete and also regardless of whether an individual with pure inner ear impairment with a completely intact middle ear or an individual with combined hearing impairment, in which the middle and inner ear is damaged, is to be rehabilitated. Therefore implantable electromechanical transducers and methods for coupling the mechanical transducer vibrations to the functioning middle ear or directly to the inner ear for rehabilitation of a pure inner ear impairment, or to a remaining ossicle of the middle ear in the case of an artificially or pathologically altered middle ear for taking care of a hearing disorder caused by a disturbance of sound conduction, or for combinations of such disorders, have been described in the recent scientific literature and in many patents.
Useful electromechanical transducer processes include basically all physical transducer principles, such as electromagnetic, electrodynamic, magnetostrictive, dielectric and piezoelectric. Various research groups, in recent years, have focused essentially on two of these processes, namely electromagnetic and piezoelectric processes. A survey can be found in ZENNER and LEYSIEFFER (HNO 10/1997, vol. 45, pp. 749-774).
In the piezoelectric process, direct mechanical coupling of the output-side transducer vibrations to the middle ear ossicle or to the oval window is essential. In the electromagnetic principle, force coupling between the transducer and ossicle, on the one hand, can take place xe2x80x9cwithout contactxe2x80x9d, i.e. via an air gap; in this case, only the permanent magnet is caused to vibrate by the transducer being in direct mechanical contact with the middle ear ossicle by permanent fixation. On the other hand, it is possible to implement the transducer entirely in a housing (in this case the coil and the magnet preferably being coupled with the smallest possible air gap) and to transmit the output-side vibrations via a mechanically stiff coupling element with direct contact to the middle ear ossicle (see FREDRICKSON et al.: Ongoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing loss; Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 107-121; and Leysieffer et al., HNO 10/97, vol. 45, pp.792-800).
The patent literature contains some of the aforementioned versions of both electromagnetic and also piezoelectric hearing aid transducers: U.S. Pat. No. 3,712,962, EPLEY; U.S. Pat. No. 3,870,832, FREDRICKSON; U.S. Pat. No. 3,882,285, NUNLEY et al.; U.S. Pat. No. 4,850,962, SCHAEFER; U.S. Pat. No. 5,015,224, MANIGLIA; U.S. Pat. No. 5,277,694, LEYSIEFFER et al.; U.S. Pat. No. 5,554,096, BALL; U.S. Pat. No. 5,707,338, ADAMS et al.; U.S. Pat. No. 6,123,660, LEYSIEFFER; U.S. Pat. No. 6,162,169, LEYSIEFFER; International Patent Application Publications WO-A 98/06235, ADAMS et al.; WO-A 98/06238, ADAMS et al.; WO-A 98/06236, KROLL et al.; WO-A 98/06237, BUSHEK et al.
The partially implantable piezoelectric hearing system of the Japanese group of Suzuki and Yanigahara presupposes, for implantation of the transducer, the absence of the middle ear ossicles and a free tympanic cavity to be able to couple the piezo element to the stapes (Yanigahara et al.: Efficacy of the partially implantable middle ear implant in middle and inner ear disorders: Adv. Audiol., Vol. 4, Karger Basel (1988), pp. 149-159; Suzuki et al.: Implantation of partially implantable middle ear implant and the indication. Adv. Audiol., Vol. 4, Karger Basel (1988), pp. 160-166). Likewise, in the method of implanting a hearing system for inner ear hearing-impaired according to SCHAEFER (U.S. Pat. No. 4,850,962) basically the incus is removed in order to be able to couple a piezoelectric transducer element to the stapes. This also applies to further developments which are based on the SCHAEFER technology and which are described in the above mentioned patents (U.S. Pat. No. 5,707,338, ADAMS et al.; International Patent Application Publications WO-A 98/06235, ADAMS et al.; WO-A 98/06238, ADAMS et al.; WO-A 98/06236, KROLL et al.; WO-A 98/06237, BUSHEK et al.).
The BALL electromagnetic transducer (xe2x80x9cFloating Mass Transducer FMTxe2x80x9d of U.S. Pat. No. 5,554,096, BALL; U.S. Pat. No. 5,624,376, BALL et al.) is, on the other hand, directly fixed to the long process of the incus when the middle ear is intact. The electromagnetic transducer of the partially implantable system of FREDRICKSON (Fredrickson et al.: Ongoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing loss, Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 107-121) is directly mechanically coupled to the body of the body of the incus when the ossicular chain of the middle ear is likewise intact. The same applies to the piezoelectric transducers of LEYSIEFFER (LEYSIEFFER et al.: An implantable piezoelectric hearing aid converter for the inner ear hearing-impaired. HNO 1997/45, pp. 792-800; U.S. Pat. No. 5,277,694, LEYSIEFFER et al.; U.S. Pat. No. 6,123,660, LEYSIEFFER; U.S. Pat. No. 6,162,169, LEYSIEFFER). Also in the electromagnetic transducer system of MANIGLIA (MANIGLIA et al.: Contactless semi-implantable electromagnetic middle ear device for the treatment of sensorineural hearing loss, Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 121-141) with the ossicular chain intact a permanent magnet is permanently mechanically fixed to the ossicular chain, but is mechanically driven via an air gap coupling by a coil.
In the described transducer and coupling versions, basically, two implantation principles can be distinguished:
a) In the case of the one principle the electromechanical transducer with its active transducer element is located itself in the middle ear region in the tympanic cavity and the transducer is directly connected there to an ossicle or the inner ear (U.S. Pat. Nos. 4,850,962, 5,015,225, 5,707,338, 5,624,376, 5,554,096, and International Patent Application publication Nos. WO 98/06235, WO 98/06238, WO 98/06236, and WO 98/06237).
b) In the other principle the electromagnetic transducer with its active transducer element is located outside of the middle ear region in an artificially formed mastoid cavity; the output-side mechanical vibrations are then transmitted to the middle or inner ear by means of mechanically passive coupling elements via suitable surgical accesses (the natural aditus ad antrum, opening of the chorda-facialis angle or via an artificial hole from the mastoid) (Fredrickson et al.: Ongoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing loss. Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 107-121; U.S. Pat. No. 5,277,694; U.S. Pat. No. 6,123,660; U.S. Pat. No. 6,162,169).
An advantage of the a) type versions is, that the transducer can be made as a so-called xe2x80x9cfloating massxe2x80x9d transducer, i.e., the transducer element does not require any xe2x80x9creactionxe2x80x9d via secure screwing to the skull bone, but it vibrates based on the laws of mass inertia with its transducer housing and transmits these vibrations directly to a middle ear ossicle (U.S. Pat. Nos. 5,624,376, 5,554,096, and 5,707,338, and International Patent Application publication no. WO 98/06236). On the one hand, this means that an implantable fixation system on the cranial vault can be advantageously omitted; on the other hand, this version disadvantageously means that bulky artificial elements must be placed in the tympanic cavity, and their long-term stability and biostability are currently not known or guaranteed, especially in the case of temporary pathological changes of the middle ear (for example, otitis media). Another major disadvantage is that the transducer together with its electrical supply line has to be transferred from the mastoid into the middle ear and must be fixed there using suitable surgical tools; this requires an expanded access through the chorda facialis angle, and thus, entails a latent hazard to the facial nerve which is located in the immediate vicinity. Furthermore, such xe2x80x9cfloating massxe2x80x9d transducers can be used merely in a very limited manner or not at all, when the inner ear is to be directly stimulated for example via the oval window, or when, due to pathological changes, for example the incus is substantially damaged or is no longer present, so that such a transducer no longer can be mechanically connected to an ossicle that is able to vibrate and is in connection with the inner ear.
A certain disadvantage of the transducer versions as per b) is that the transducer housing is to be attached to the cranial vault with the aid of implantable positioning and fixation systems (advantageous embodiment U.S. Pat. No. 5,788,711). A further disadvantage of the transducer versions as per b) is that a recess is to be made, preferably by an appropriate laser, in the respective ossicle in order to allow the application of the coupling element. This, on the one hand, is technically complicated and expensive and, on the other hand, involves risks for the patient. Both in the partially implantable system of FREDRICKSON (xe2x80x9cOngoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing lossxe2x80x9d, Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 107-121) as well as in the fully implantable hearing system of LEYSIEFFER and ZENNER (HNO 1998, vol. 46, 853-863 and 844-852), when the vibrating transducer part is coupled to the body of the incus, it is assumed that for permanent and mechanically secure vibration transmission the tip of the coupling rod which is placed in the laser-induced depression of the middle ear ossicle undergoes osseointegration over the long term, i.e., the coupling rod coalesces solidly with the ossicle and thus ensures reliable transmission of dynamic compressive and tensile forces. However, this long-term effect is currently not yet scientifically proven or certain. Furthermore, in this type of coupling, in case of a technical transducer defect, there is the disadvantage that decoupling from the ossicle to remove the transducer can only be done with mechanically based surgical methods; this can mean considerable hazard to the middle ear and especially the inner ear. Therefore further coupling elements, partly involving novel surgical access paths, were developed which minimize or no longer have the above mentioned disadvantages (U.S. Pat. No. 5,941,814, LEHNER et al., commonly owned U.S. patent application Ser. Nos. 09/576,009; 09/613,560; 09/626,745; 09/680,489).
The major advantage of these converter embodiments as per b), however, is that the middle ear remains largely free and coupling access to the middle ear can take place without major possible hazard to the facial nerve. One preferable surgical process for this purpose is described in U.S. Pat. No. 6,077,215, LEYSIEFFER. Basic advantageous forms of passive coupling elements for transmission of the output-side transducer vibrations from the mastoid to the middle ear or inner ear are described in U.S. Pat. Nos. 5,277,694 and 5,941,814.
In the last years partially and fully implantable hearing systems of the above described type were chronically implanted in human patients. The long-time results show the following effects:
for the implantation of the xe2x80x9cfloating massxe2x80x9d transducer (FMT) and the use of a partial implant it could be demonstrated in a statistically significant manner that the residual audition is not or only slightly impaired by the implantation of the FMT as long as the driver electronics of the implant are switched off, because this transducer has a very low mass which is in the order of the mass of the ossicle itself, and that in view of the xe2x80x9cfloatingxe2x80x9d principle of the transducer a stiffening of the ossicular chain does not occur or occurs to a minor extent only (e.g. because of the stiffness of the transducer feed line);
in the implantation of mechanically directly coupled transducers in conformity with the above discussed embodiments as per b) it turned out that particularly in the case of transducers based on the piezoelectric principle and with high mechanical output impedance (U.S. Pat. No. 5,277,694) the residual audition may be distinctly reduced when the driver electronics are switched off, because in this case the high mechanical output impedance of the transducer dominates at the site of coupling to the ossicular chain and therefore the acoustic energy irradiated via the tympanic membrane is substantially reflected at the site of coupling.
Today, the aspect of essentially maintaining the acoustic residual audition is considered to be of importance, particularly when, in view of the design of the entire implant system, an interruption of the ossicular chain to avoid feedback or/and to optimize the transmission of energy into the inner ear is not provided for. Such an implant design e.g. may consist in providing a digital signal processor and software-based algorithms to avoid or substantially reduce feedback effects (U.S. Pat. No. 6,128,392).
Basically it is therefore desired to use an arrangement which, by preventing the ossicle from being xe2x80x9cbraked to standstillxe2x80x9d by the transducer coupled thereto, as far as possible retains the residual audition when the electronic implant system is inoperative, particularly when using mechanically directly coupled electromagnetic transducers for implantable hearing systems having a mechanical output impedance which is higher than the mechanical load impedance of the middle and/or inner ear structure coupled thereto. Maintaining the residual audition here is to be understood to the effect that the sound energy incoming via the external ear is picked up via the tympanic membrane largely undiminished, and is transmitted to the inner ear as mechanical vibratory energy.
Possible proposals of solution therefor are disclosed in commonly owned U.S. patent application Ser. Nos. 09/576,009 and 09/626,745, where the vibrating output element of an electromechanical transducer having a high mechanical output impedance is not directly coupled to the selected ossicle by metallic contact; rather coupling is effected through adhesion forces or via an entropy-elastic intermediate layer made e.g. of silicone. Thereby the mechanical source impedance of the transducer is reduced. A further advantage of such a coupling, e.g. an adhesion coupling, is that the ossicle is not xe2x80x9crestrainedxe2x80x9d mainly in the direction of vibration of the driving transducer, since such xe2x80x9crestraintxe2x80x9d can lead to a less than optimum form of vibration of the footplate of the stapes in the oval window. (One preferable form of vibration is a piston-like vibration of the footplate of the stapes perpendicular to its plane). Rather, the ossicle sets itself its (frequency-dependent) direction of vibration based on the dynamic properties of the intact middle ear. This advantage also applies to a non-intact, (partially) decomposed ossicular chain and coupling to the xe2x80x9cremainderxe2x80x9d of the chain facing the inner ear, and in the extreme case, also to only a residual stapes or only the footplate of the stapes since it is suspended by the so-called ligament (the elastic annular ligament which xe2x80x9choldsxe2x80x9d the stapes in the oval window). So far, however, there are no practical experiences with such an approach and thus no proof for the functionality thereof as to the main aspect of the subject invention.
A primary object of the present invention is to devise an at least partially implantable hearing system which maintains in a particularly reliable manner the residual audition of the user of the hearing system when the electronic implant system is inoperative.
This object is achieved in that, in an at least partially implantable hearing system for rehabilitation of a hearing disorder comprising at least one acoustic sensor for picking up an acoustic signal and converting the acoustic signal into corresponding electrical audio sensor signals, an electronic signal processing unit for audio signal processing and amplification, an electrical power supply unit which supplies individual components of the system with energy, and at least one electromechanical output transducer driven by an electronic driver arrangement of the signal processing unit, wherein the electromechanical output transducer is provided with an active electromechanical element and an output member for stimulating, via a passive coupling element, an ossicle of a middle ear ossicular chain, which chain has a natural capability for vibratory movement, according to the invention, a switchable clutch arrangement is disposed between the active electromechanical element of the transducer and the passive coupling element, wherein in an inactive condition of the electronic driver arrangement the clutch arrangement disconnects the passive coupling element from the output member of the transducer to such an extent that the mechanical output impedance of the transducer has substantially no influence on the natural capability of the ossicular chain for vibratory movement.
When in the hearing system of the invention the electronic implant system is inactive, i.e. inoperative, for whatever reason, the active electromechanical element of the transducer is decoupled from the passive coupling element and thus from the ossicular chain. This avoids that vibrations of the ossicular chain resulting from acoustic signals are impaired or prevented by the electromechanical transducer which otherwise, i.e. during normal operation of the hearing system, is mechanically directly coupled to the ossicular chain, or, stated otherwise, that acoustic energy which is incoming via the tympanic membrane is reflected to a substantial extent at the coupling site. Accordingly, the sound energy which enters through the external ear and which is picked up by the tympanic membrane is transmitted to the inner ear substantially without reduction. Therefore, the residual audition of the user of the hearing system is maintained to a substantial extent.
The solution in accordance with the invention is of particular importance when the hearing system has a mechanical output impedance which is higher than the mechanical load impedance of the biological middle ear and/or inner ear structure coupled thereto.
The term xe2x80x9cswitchablexe2x80x9d used here in connection with the clutch arrangement is to be understood in a broad sense. It is by no means restricted to a force- or form-locking interconnection in the xe2x80x9cswitched onxe2x80x9d condition, and a complete separation of the active electromechanical transducer element from the passive coupling element in the xe2x80x9cswitched offxe2x80x9d condition of the clutch arrangement. Rather it is intended to generally include all cases in which there is a substantial difference between the xe2x80x9cswitched onxe2x80x9d condition and the xe2x80x9cswitched offxe2x80x9d condition of the switchable clutch arrangement as to the mechanical output impedance of the output transducerxe2x80x94in relation to the side of the clutch arrangement remote from the transducer. Preferably, the switchable clutch arrangement is designed such that there is a difference of at least 10 dB in the mechanical load impedance between switched-on condition and the switched-off condition of the clutch arrangement.
In view of the confined space situation at the site of implantation and in order to keep the vibrating masses small, the switchable clutch arrangement is preferably manufactured using Microsystems engineering techniques, for example, photolithography. Advantageously, the clutch arrangement comprises an electromechanically active member, particularly a piezoelectric element. The active electromechanical element of the transducer and the clutch arrangement may be housed in a common casing. This simplifies controlling of the clutch arrangement and avoids an additional clutch casing.
The passive coupling element and the active electromechanical element of the transducer may be mechanically interconnected in a known manner via a coupling rod. In that case the clutch arrangement may be incorporated into the coupling rod or disposed between the active electromechanical element of the transducer and the end of the coupling rod facing the transducer.
Preferably, the electronic signal processing unit is designed to also control the clutch arrangement. Advantageously, the signal processing unit comprises a digital signal processor which provides for controlling the clutch arrangement as well as for processing the audio sensor signals and/or for generation of digital signals for tinnitus masking.
The signal processing unit can be designed to be static such that as a result of scientific findings respective software modules are filed once in a program storage of the signal processor and remain unchanged. But then if later, for example due to more recent scientific findings, improved algorithms for signal processing are available and these improved algorithms are to be used, the entire implant or implant module which contains the corresponding signal processing unit must be replaced by a new unit with the altered operating software by invasive surgery on the patient. This surgery entails renewed medical risks for the patient and is very complex.
This problem can be solved in that, in another embodiment of the invention, a rewritable implantable storage arrangement is assigned to the signal processor for storage and retrieval of an operating program and at least parts of the operating program are adapted to be at least partially replaced or changed by data transmitted from an external unit via a telemetry means. In this way, after implantation of the implantable system the operating software as such can be changed or completely replaced, as is explained for otherwise known systems for rehabilitation of hearing disorders in U.S. Pat. No. 6,198,971.
Preferably, the design is such that, in addition, for fully implantable systems, in the known manner, operating parameters, i.e., patient-specific data, for example, audiological adaption data, or variable implant system parameters (for example, as a variable in a software program for controlling the clutch arrangement or for control of battery recharging) can be transmitted transcutaneously into the implant after implantation, i.e., wirelessly through the closed skin, and thus, can be changed. Here, preferably, the software modules are designed to be dynamic or re-programmable to provide for an optimum rehabilitation of the respective hearing disorder. In particular, the software modules can be designed to be adaptive, and parameter matching can be done by training by the implant wearer and optionally by using other aids.
Furthermore, the signal processing electronics can contain a software module which achieves simulation as optimum as possible based on an adaptive neural network. Training of this neural network can take place again by the implant wearer and/or using other external aids.
The storage arrangement for storage of operating parameters and the storage arrangement for storage and retrieval of the operating program can be implemented as storages independent of one another; however there can also be a single storage in which both the operating parameters and also operating programs can be filed.
The subject approach allows matching of the system to circumstances which can be detected only after implantation of the implantable system. Thus, for example, in an at least partially implantable hearing system for rehabilitation of a monaural or binaural inner ear disorder and of a tinnitus by mechanical stimulation of the inner ear, the sensoric (acoustic sensor or microphone) and actoric (output stimulator) biological interfaces are always dependent on anatomic, biological and neurophysiological circumstances, for example on the interindividual healing process. These interface parameters can also be individual, also especially time-variant. Thus, for example the transmission behavior of an implanted microphone can vary interindividually and individually as a result of being covered by tissue, and the transmission behavior of an electromechanical transducer which is coupled to the inner ear can vary in view of on different coupling qualities. These differences of interface parameters which cannot be eliminated or reduced in the devices known from the prior art even by replacing the implant can now be optimized by changing or improving the signal processing of the implant.
In an at least partially implantable hearing system, it can be advisable or become necessary to implement signal processing algorithms which have been improved after implantation. Especially the following should be mentioned here:
speech analysis processes (for example, optimization of a fast Fourier transform (FFT))
static or adaptive noise detection processes
static or adaptive noise suppression processes
processes for optimization of the signal to noise ratio within the system
optimized signal processing strategies in progressive hearing disorder
output level-limiting processes for protection of the patient in case of implant malfunctions or external faulty programming
processes of preprocessing of several sensor (microphone) signals, especially for binaural positioning of the sensors
processes for binaural processing of two or more sensor signals in binaural sensor positioning, for example optimization of spacial hearing or spacial orientation
phase or group delay time optimization in binaural signal processing
processes for optimized driving of the output stimulators, especially for binaural positioning of the stimulators.
Among others, the following signal processing algorithms can be implemented with this system even after implantation:
processes for feedback suppression or reduction
processes for optimization of the operating behavior of the output transducer(s) (for example, optimization of the frequency response and phase response, improvement of the impulse response)
speech signal compression processes for sensorineural hearing loss
signal processing methods for recruitment compensation in sensorineural hearing loss.
Furthermore, in implant systems with a secondary power supply unit, i.e., a rechargeable battery system, but also in systems with primary battery supply it can be assumed that these electrical power storages will enable longer and longer service lives and thus increasing residence times in the patients as technology advances. It can be assumed that fundamental and applied research for signal processing algorithms will make rapid progress. The necessity or the patent desire for operating software adaptation and modification will therefore presumably take place before the service life of the implanted power source expires. The system described here allows this adaptation of the operating programs of the implant even when the implant has already been implanted.
Preferably, there can furthermore be provided a buffer storage arrangement in which data transmitted from the external unit via the telemetry means can be buffered before being relayed to the signal processor. In this way the transmission process from the external unit to the implanted system can be terminated before the data transmitted via the telemetry means are relayed to the signal processor.
Furthermore, there can be provided checking logic which checks the data stored in the buffer storage arrangement before relaying the data to the signal processor. There can be provided a microprocessor module, especially a microcontroller, for control of the A/D-converters and/or the D/A converters and/or the signal processor within the implant via a data bus, preferably the checking logic and the buffer storage arrangement being implemented in the microprocessor module, and wherein also program parts or entire software modules can be transferred via the data bus and the telemetry means between the outside world, the microprocessor module and the signal processor.
An implantable storage arrangement for storing the working program for the microprocessor module is preferably assigned to the microprocessor module, and at least parts of the working program for the microprocessor module can be changed or replaced by data transmitted from the external unit via the telemetry means.
In another embodiment of the invention, at least two storage areas for storage and retrieval of at least the operating program of the signal processor may be provided. This contributes to the reliability of the system, in that due to the multiple presence of a storage area which contains the operating program(s), for example, after transmission from the exterior or when the implant is turned on, checking for the absence of faults in the software can be done.
Analogously to the above, the buffer storage arrangement can also comprise at least two storage areas for storage and retrieval of data transferred from the external unit via the telemetry means, so that after data transmission from the external unit still in the area of the buffer storage the absence of errors in the transferred data can be checked. The storage areas can be designed for example for complementary filing of the data transferred from the external unit. At least one of the storage areas of the buffer storage arrangement however can also be designed to store only part of the data transferred from the external unit, wherein in this case the absence of errors in the transferred data is checked in sections.
Furthermore, to ensure that in case of transmission errors, a new transmission process can be started, a preprogrammed read-only memory area which cannot be overwritten can be assigned to the signal processor, in which ROM area the instructions and parameters necessary for xe2x80x9cminimum operationxe2x80x9d of the system are stored, for example, instructions which after a xe2x80x9csystem crashxe2x80x9d ensure at least error-free operation of the telemetry means for receiving an operating program and instructions for its storage in the control logic.
As already mentioned, the telemetry means is advantageously designed not only for reception of operating programs from the external unit but also for transfer of operating parameters between the implantable part of the system and the external unit such that on the one hand such parameters (for example the volume) can be adjusted by a physician, a hearing aid acoustics specialist or the wearer of the system himself, and on the other hand the system can also transfer the parameters to the external unit, for example to check the status of the system.
A totally implantable hearing system of the aforementioned type can have on the implant side in addition to the actoric stimulation arrangement and the signal processing unit at least one implantable acoustic sensor and a rechargeable electrical storage element, and in this case a wireless transcutaneous charging device can be provided for charging of the storage element. For a power supply there can also be provided a primary cell or another power supply unit which does not require transcutaneous recharging. This applies especially when it is considered that in the near future mainly by continuing development of processor technology a major reduction in power consumption for electronic signal processing can be expected so that for implantable hearing systems new forms of power supply will become usable in practice, for example power supply which uses the Seebeck effect, as is described in U.S. Pat. No. 6,131,581. Preferably, there is also provided a wireless remote control for control of the implant functions by the implant wearer.
In case of a partially implantable hearing system, at least one acoustic sensor, an electronic signal processing arrangement, a power supply unit and a modulator/transmitter unit are contained in an external module which can be worn outside on the body, especially on the head over the implant. The implant comprises the output-side electromechanical transducer and the intracochlear stimulation electrode array, but is passive in terms of energy and receives its operating energy and transducer control data via the modulator/transmitter unit in the external module.
The described system can be designed to be monaural or binaural for the fully implantable design as well as for the partially implantable design. A binaural system for rehabilitation of a hearing disorder of both ears has two system units which each are assigned to one of the two ears. In doing so the two system units can be essentially identical to one another. However, one of the system units can also be designed as a master unit and the other system unit as a slave unit which is controlled by the master unit. The signal processing modules of the two system units can communicate with one another in any way, especially via a wired implantable line connection or via a wireless connection, preferably a bidirectional high frequency path, a ultrasonic path coupled by bone conduction, or a data transmission path which uses the electrical conductivity of the tissue of the implant wearer such that in both system units optimized binaural signal processing and transducer array control are achieved.
These and further objects, features and advantages of the present invention will become apparent from the following description when taken in connection with the accompanying drawings which, for purposes of illustration only, shows several embodiments in accordance with the present invention.